Study Of CP-751,871 In Combination With Cisplatin And Gem... | NCT00560573

Label	Type	Description	Intervention Names
1	Experimental		Drug: CP-751,871 Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
CP-751,871	Drug	CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).

Measure	Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLT)	Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment	Start of treatment up to end of Cycle 1, Day 21

Measure	Description	Time Frame
Concentration at the End of Infusion (Cinf) for Figitumumab	Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods	Cycle 1 for dose escalation and Cycle 4 for dose expansion
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD)	The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1	Cycle 1, up to Day 21
Recommended Phase 2 Dose (RP2D)

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Charleroi		6000	Belgium
Pfizer Investigational Site

ID	Title	Description
FG000	Figitumumab 6 mg/kg	Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

ID	Title	Description
BG000	All Participants	Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.

Units	Counts
Participants	BG00045

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose-limiting Toxicities (DLT)

Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment

Safety analysis set: All enrolled participants in the dose escalation who received at least 1 dose of study medication.

Posted

Number

participants

Start of treatment up to end of Cycle 1, Day 21

ID	Title	Description
OG000	Figitumumab 6 mg/kg	Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Figitumumab 10 mg/kg	Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG002	Figitumumab 20 mg/kg Dose Escalation	Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Units	Counts
Participants	OG0006 OG0013 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0021

Secondary

Concentration at the End of Infusion (Cinf) for Figitumumab

Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

mg/liter (L)

Cycle 1 for dose escalation and Cycle 4 for dose expansion

ID	Title	Description
OG000	Figitumumab 6 mg/kg	Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Figitumumab 10 mg/kg	Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG002	Figitumumab 20 mg/kg Dose Escalation

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

mg*hr/L

0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion

ID	Title	Description
OG000	Figitumumab 6 mg/kg	Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Figitumumab 10 mg/kg	Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab

Concentration at the end of Cycle 4

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

mg/L

0 (pre-dose) in Cycle 5 Day 1

ID	Title	Description
OG000	Figitumumab 20 mg/kg Expansion	The RP2D of figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Plasma Concentration (Cmax) for Cisplatin

Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

nanogram (ng)/mL

0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2

ID	Title	Description
OG000	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

ng*hr/L

ID	Title	Description
OG000	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Maximum Observed Plasma Concentration (Cmax) for Gemcitabine

Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

ng/L

0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8

ID	Title	Description
OG000	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 (absence) and on Day 1 of each cycle (presence) thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

ng*hr/L

0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8

ID	Title	Description
OG000	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Maximum Observed Plasma Concentration (Cmax) for Pemetrexed

Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

ng/mL

0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2

ID	Title	Description
OG000	Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
OG001	Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Posted

Mean

Standard Deviation

ng*hr/L

0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2

ID	Title	Description
OG000	Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
OG001	Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Percentage of Participants With Objective Response or Prolonged Stabilization

Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response

Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.

Posted

Number

95% Confidence Interval

Percentage of participants

Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

ID	Title	Description
OG000	Overall Population	Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
OG001	Figitumumab 20 mg/kg With Gemcitabine and Cisplatin

Secondary

Progression-Free Survival (PFS)

Time from the date of enrollment to date of documented disease progression, or death due to any cause

Posted

Median

95% Confidence Interval

months

Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

ID	Title	Description
OG000	Overall Population	Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
OG001	Figitumumab 20 mg/kg With Gemcitabine and Cisplatin	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.

Secondary

Duration of Response (DR)

For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression

No analysis of this parameter was performed. Due to the exploratory nature of the study, the analysis of the efficacy of figitumumab was limited to the assessment of clinical benefit response and PFS.

Posted

Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

ID	Title	Description
OG000	Overall Population With PR and CR	Participants with PR and CR who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants with PR and CR who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab

Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab

ADA analysis set: All enrolled participants who received at least 1 dose of study medication.

Posted

Number

Percentage of participants

30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)

ID	Title	Description
OG000	Figitumumab 6 mg/kg	Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG001	Figitumumab 10 mg/kg	Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
OG002

Secondary

Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels

To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment

Biomarker analysis set: All enrolled participants who received at least 1 dose of study medication.

Posted

Mean

Inter-Quartile Range

ng/mL

Baseline, Day 8, end of study

ID	Title	Description
OG000	Overall Population	Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.

Units	Counts
Participants	OG000

Other Pre-specified

Maximum Tolerated Dose (MTD)

The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1

Safety analysis set: All enrolled participants who received at least 1 dose of study medication.

Posted

Number

mg/kg

Cycle 1, up to Day 21

ID	Title	Description
OG000	Overall Population	Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.

Units	Counts
Participants	OG000

Other Pre-specified

Recommended Phase 2 Dose (RP2D)

The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration

Safety analysis set: All enrolled participants who received at least 1 dose of study medication.

Posted

Number

mg/kg

Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19

ID	Title	Description
OG000	Overall Participapnts	Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG0030 affected10 at risk EG004
Neutropenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blindness unilateral	Eye disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Asthenia	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Chest pain	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Death	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Disease progression	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
General physical health deterioration	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pain	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Pyrexia	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Sudden death	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Bronchitis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Diverticulitis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Lung infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pneumonia	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Sepsis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Septic shock	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Blood creatinine increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood glucose increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood urea increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Carbon dioxide increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Platelet count decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
White blood cell count decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Myoclonus	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Arterial thrombosis	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Arterial thrombosis limb	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Embolism	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0004 affected6 at risk EG0010 affected3 at risk EG0023 affected6 at risk EG0032 affected10 at risk EG0045 affected7 at risk EG0055 affected13 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0005 affected6 at risk EG0012 affected3 at risk EG0025 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v13.0	Non-systematic Assessment	EG0005 affected6 at risk EG0011 affected3 at risk EG0022 affected6 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Ventricular dysfunction	Cardiac disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Motion sickness	Ear and labyrinth disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Ototoxicity	Ear and labyrinth disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0023 affected6 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Conjunctivitis	Eye disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Keratoconjunctivitis sicca	Eye disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Vision blurred	Eye disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Visual impairment	Eye disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Anal stenosis	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Anorectal discomfort	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0004 affected6 at risk EG0010 affected3 at risk EG0023 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0011 affected3 at risk EG0023 affected6 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected3 at risk EG0022 affected6 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Lip haemorrhage	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0006 affected6 at risk EG0011 affected3 at risk EG0024 affected6 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Periodontitis	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Tooth disorder	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected3 at risk EG0024 affected6 at risk EG003
Asthenia	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0004 affected6 at risk EG0012 affected3 at risk EG0025 affected6 at risk EG003
Chest pain	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Chills	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Disease progression	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0012 affected3 at risk EG0022 affected6 at risk EG003
Fatigue	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0011 affected3 at risk EG0022 affected6 at risk EG003
Hypothermia	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Mucosal dryness	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Mucosal inflammation	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0011 affected3 at risk EG0022 affected6 at risk EG003
Oedema peripheral	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pain	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Performance status decreased	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pyrexia	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0023 affected6 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Bacteriuria	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Bronchitis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Candidiasis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Cellulitis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Cystitis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Oral infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Oropharyngeal candidiasis	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Paronychia	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Activated partial thromboplastin time shortened	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood albumin decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood bilirubin increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood calcium decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood chloride decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood chloride increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Blood creatine increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood creatinine increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Blood glucose increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood immunoglobulin A decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood immunoglobulin G decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood magnesium decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Blood magnesium increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood phosphorus increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Blood potassium increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood sodium decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Blood urea increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Blood uric acid increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Glucose urine present	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Glutamate dehydrogenase increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Haemoglobin decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Lipase increased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Platelet count decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0011 affected3 at risk EG0022 affected6 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Weight decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
White blood cell count decreased	Investigations	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0005 affected6 at risk EG0012 affected3 at risk EG0025 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Hyperproteinaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Amnesia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Aphonia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Dyskinesia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Hypokinesia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Neurotoxicity	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0023 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Somnolence	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Syncope	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Tremor	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Bradyphrenia	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Depression	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Disorientation	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Hallucination	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Mood altered	Psychiatric disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected3 at risk EG0023 affected6 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0004 affected6 at risk EG0011 affected3 at risk EG0022 affected6 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Madarosis	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0021 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003
Pallor	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected3 at risk EG0022 affected6 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected3 at risk EG0020 affected6 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Figitumumab 6 mg/kg	Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	3	6	6	6
EG001	Figitumumab 10 mg/kg	Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	2	3	3	3
EG002	Figitumumab 20 mg/kg Dose Escalation	Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	3	6	6	6
EG003	Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	7	10	10	10
EG004	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	2	7	7	7
EG005	Figitumumab 20 mg/kg Pemetrexed Expansion	The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.	8	13	13	13

ID	Term
C525021	figitumumab
D002945	Cisplatin
D000093542	Gemcitabine
D000068437	Pemetrexed